New clinical trial aims to prevent relapse in patients with DLBCL

June 23, 2025 at 00:01 AM EDT

(BPT) - For many patients diagnosed with diffuse large B-cell lymphoma (DLBCL), the first step in treatment is a standard regimen of chemotherapy. This approach cures most patients, but research shows that one in three will see their cancer return - typically within a year following completion of their initial treatment.[1] Today, the current standard of care following initial chemotherapy is to "watch and wait," an approach that monitors the patient for signs of relapse.

But what if there were a way to identify patients at risk of relapse earlier and treat them before the cancer has a chance to come back? That's the goal of the ALPHA3 clinical trial, a groundbreaking study investigating whether early intervention with an investigational CAR T cell product (cemacabtagene ansegedleucel or cema-cel, pronounced "SEM-a-sell") can help prevent relapse in DLBCL patients. CAR T therapy is a revolutionary approach to treating cancer that has shown promising results and high remission rates, particularly when used in blood cancers[2].

A New Approach May Predict and Prevent Relapse

The ALPHA3 trial uses an investigational blood test designed to find signs of cancer earlier, often well before it shows up on scans. The test looks for minimal residual disease, known as MRD, or traces of cancer left in the blood after chemotherapy that are too small to be seen on scans. Being MRD positive can indicate whether or not a patient is at high risk of their cancer coming back, also known as relapse.[3]

If MRD is detected, patients may be eligible to join the ALPHA3 trial, where they will be randomly assigned to one of two groups. One group would undergo more thorough observation, and the other group would undergo treatment with cema-cel. Unlike traditional treatments given after relapse occurs, cema-cel is administered as a one-time infusion shortly after MRD is detected and is designed to target and eliminate the remaining cancer cells in the body, potentially preventing relapse before it happens.

Why Early Intervention Matters

Research suggests that treating cancer when it is still microscopic - before it grows large enough to appear on scans - may improve outcomes.[4] Think of it like putting out a fire as soon as you see the first puff of smoke rather than waiting until the flames spread. By intervening early, the ALPHA3 trial aims to improve cure rates for DLBCL patients who are at high risk of relapse.

What Makes the ALPHA3 Trial Different?

Older woman talking with doctor in an exam room

Most clinical trials test new treatments only after cancer has relapsed and grown large enough to be detected on scans. The ALPHA3 trial takes a different approach by focusing on prevention. It combines cutting-edge MRD testing technology with a novel CAR T cell therapy to address cancer at its earliest stages.

This innovative approach could transform the treatment landscape for DLBCL patients, offering hope to those who might otherwise face relapse and more intensive treatments down the road.

For more information to share with your patients about the ALPHA3 trial, visit DLBCL.ClinicalEnrollment.com.

[1] Tilly H., et al: Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. 2021

[2] Estimation of eligibility for and response to CAR-T therapy in the United States. Haslam, A. Blood Adv (2024) 8 (4): 1032-1036.https://doi.org/10.1182/bloodadvances.2023011184

[3] Foresight Diagnostics. Foresight Diagnostics Presents Independent Validation of its CLARITY Minimal Residual Disease Assay in Multi-center Study of Frontline DLBCL at the 2025 ASCO Annual Meeting. LINK

[4] ALPHA/ALPHA2 Phase 1 data, Locke FL, et al. J Clin Oncol. 2025

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New clinical trial aims to prevent relapse in patients with DLBCL

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